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Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of PF-4217903 in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of PF-4217903 in Patients With Advanced Cancer


The study was prematurely discontinued due to a strategic development decision by Pfizer on
10FEB2012. The decision to terminate was not based on any safety concerns.


Inclusion Criteria:



- Advanced solid tumors, histologically proven at diagnosis which is refractory to
standard of care or for whom no standard of care therapy is available

- Adequate blood cell counts, normal kidney function, and performance status of 0 or 1

Exclusion Criteria:

- Major surgery, radiation therapy or anti-cancer therapy within 2 weeks of starting
study treatment

- Prior stem cell transplant

- Active or unstable cardiac disease or heart attack within 12 months of starting study
treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.

Outcome Time Frame:

Baseline up to 21 days after the start of each increased treatment dose

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B0331002

NCT ID:

NCT00706355

Start Date:

August 2008

Completion Date:

June 2011

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site North Adams, Massachusetts  01247